Study Comparing Traditional and Gender-specific Total Knee Replacement Designs

UConn Health

Status: Withdrawn

Conditions: Knee Osteoarthritis

Treatments: Device: Zimmer High Flex LPS Implant (Total knee replacement); Device: Zimmer LPS flex Gender Specific Implant (Total knee replacement); Device: Stryker Triathlon Implant (Total knee replacement)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00937170

RMM001

09-036C-2

Details and patient eligibility

About

The purpose of this study is to compare results obtained with gender-specific and traditional knee replacement systems design among women undergoing total knee replacement surgery. Women who qualify and agree to participate will be randomly assigned to receive either a traditional or gender-specific knee replacement. During surgery, measurements of bone resection and bone-to-implant relationships will be recorded. At selected time intervals, participants will be asked to fill out questionnaires regarding pain and function, will be examined by their surgeon and routinely obtained xrays will be evaluated. In addition, a subset of participants will be randomly selected to undergo gait analysis to evaluate knee motion and muscle function.

Sex: Female

Ages: 40 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• clinical diagnosis of end-stage degenerative joint disease of the knee
• must be deemed appropriate for total knee replacement surgery

Exclusion criteria

• severe flexion deformity of the knee
• greater than 20deg varus or valgus malalignment
• osteomyelitis, septicemia, prior infection of the knee joint
• presence of infections or highly communicable diseases
• significant neurological or musculoskeletal disorders that affect gait or ability to bear weight on lower extremity
• metastatic disease
• congenital, developmental, bone disease or previous knee surgery that may interfere with the total knee prosthesis survival or success
• previous total knee replacement in affected knee
• arthrodesis of the affected knee

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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0 participants in 3 patient groups

Gender Specific LPS flex

Experimental group

Description:

Participants in this arm will receive the Zimmer LPS flex Gender Specific Implant design

Treatment:

Device: Zimmer LPS flex Gender Specific Implant (Total knee replacement)

LPS flex

Active Comparator group

Description:

Participants in this arm will receive the Zimmer High Flex LPS implant

Treatment:

Device: Zimmer High Flex LPS Implant (Total knee replacement)

Triathlon

Active Comparator group

Description:

Participants in this arm will receive the Stryker Triathlon Implant design

Treatment:

Device: Stryker Triathlon Implant (Total knee replacement)